The Coming Health Care Apartheid

Paul Krugman tackles the weighty question of how much health care society can afford and who should pay for it in this morning's New York Times. His critique of the Bush administration proposal to use individual health savings accounts to drive those decisions -- it's called "consumer driven health care" -- points out the obvious: no individual savings account, no matter how well it is designed, can afford to pick up the really big health care bills that hit people with serious, often terminal chronic conditions like cancer, heart disease and diabetes.

The bills from these diseases can bankrupt even the upper middle class in our society. Add to that the fact that the incidence of serious illness is closely associated with poverty, stress and low social status and it's easy to see that health savings accounts are nothing more than free market ideology masquerading as social policy. How likely are the poor and near poor to save for those unhealthy rainy days when they can't even save for their own retirement?

Eventually, the government will get stuck with the tab. As Krugman rightly points out, health care -- like food and housing -- ultimately is a social responsibility. Society, i.e., the government, will have to face up to its responsibility to provide for those who can't provide for themselves.

But what will society provide? The coming debate over health care reform will be ugly. It's not being driven by concern for the nation's 45 million uninsured or the savage inequities in the current system or what new drugs, devices and expensive imaging technologies meet a reasonable test of cost effectiveness.

Rather, health care reform is being put back on the political agenda by a corporate sector that is just a few bankruptcies away (can anyone say General Motors?) from pulling its support from the employer-based system that has undergirded American health care policy since the 1940s.

Where will corporate America go? Will it opt for a government-run system -- Medicare for all? -- that tries to make rational decisions about what health care the system should provide for everyone, which is the subject of the new Brookings Institution study Can We Say No?, that Krugman touts today. Or will it embrace a form of health care apartheid that is growing up in the belly of the current failing system.

In this emerging system, most of the very sick, once they've exhausted all their health care savings accounts and other assets, will get thrown into a public sector-financed health care system that provides minimal care. The quality of care will be determined by the costs of the technologies deployed, the salaries paid to its personnel and the maintenance of its facilities, all of which will be seriously underfinanced because the system has to compete for the scarce resources of an impoverished public sector to which the very rich refuse to pay taxes.

Meanwhile, the very well-to-do will either finance their own health care or buy expensive catastrophic insurance financed by a self-selecting pool of upper middle class people who have on average far fewer debilitating illnesses and can afford the high premiums.

Health care providers will be more than happy to cater to this two-tier health care system. As we've seen in virtually every other walk of American life, there's a lot of money to be made in catering exclusively to the rich. The coming debate is not about what technologies "we" should buy. It's about whether there is any "we" at all.

Gone Shopping -- for a new drug

The big drug news on the financial pages yesterday was AstraZeneca's $1 billion deal to buy Artherogenics, an Atlanta-based start-up company with a new heart drug. The business pages cut this story as a play by a foundering AZ to get something promising into its impoverished new drug pipeline.

Evidence that Artherogenics new drug works -- it's a heart attack preventive measure that many will take on top of taking cholesterol-lowering drugs -- merits close scrutiny. A little over a year ago, Dr. Eric Topol accused the company of fudging the data on its clinical trials. "The company has fully manipulated the reanalysis that was performed at our center, not having presented the planned, original, primary analysis and has thus shirked its responsibility to report the truth," he wrote. You can read his full article here.

Don't Like the Data? Pay Someone To Reinterpret It

The Wall Street Journal carried a front page story today on how an industry, seeking to effect the way the government regulates a pollutant, hired scientists to reinterpret and ghostwrite changes in a Chinese study that suggested it was toxic. It's a chrome-plated tale that perfectly illustrates the growing problem of corporate influence over science and science-based policy. I can't link to it here because the Journal requires a subscription for online access, but don't miss it.

Deceptive Advertising, Journal Alleges

The ads are everywhere. Smiling people in picturesque settings with the energy to enjoy life even though they're undergoing chemotherapy. Why? Their peppy outlook is due to Aranesp, the anti-anemia drug made by Amgen, the ads say.

That's not what the medical evidence says. In a study that appeared this week in the Journal of Palliative Medicine, physicians at the M.D. Anderson Cancer Center in Houston report that anemia "is not one of the major contributors to fatigue in patients with cancer receiving palliative care." Numerous studies have appeared in the medical literature -- mostly funded by Amgen -- claiming that taking erythropoietin to raise red blood cell counts (the drug form is sold under the Procrit, Epogen and Aranesp labels) will decrease fatigue.

Fatigue among cancer patients "is a multidimensional symptom," caused by depression and anxiety, pain, infections, inactivity and all the other things that might make someone who is very sick "tired." Maybe the last thing in the world they need is another drug.

The editor of the journal, Charles von Gunten, wrote an angry editorial condemning Amgen's massive advertising campaign. "These data will help physicians resist the patient and family pressure to use erythropoietin because they saw it on television. There are different things that can be done to relieve fatigue. Erythropoietin is ineffective in relieving fatigue if anemia is not the cause. It is an expensive placebo."

Well said.

Correction on Richard Berman

Earlier this week, I posted an item on the Center for Consumer Freedom's latest advertising campaign (see the Dec. 19 post). After receiving a phone call from Richard Berman, who runs CCF and his own management company, I realize I made an error in the posting. The CCF did not make a $115,000 payment to Berman's personal retirement fund. It made a $115,000 payment to Berman and Company for "employee benefit plans and deferred compensation." The Center also made a $1.14 million payment to Berman and Company for "compensation." After reviewing his company's records, he said the $115,000 was listed as deferred compensation for the company because it was owed by Center for Consumer Freedom. It was not an employee benefit plan of a company which, he confirmed, he 100 percent owns. I regret the error.

New Cancer Drug Approved, But Does It Prolong Life?

The New York Times reports this morning on the FDA's approval of a new cancer drug based on data showing it shrinks kidney tumors. This is one of the first fruit's of the new regime at the FDA, which is now headed by National Cancer Institute director and Bush family friend Andrew von Eschenbach.

As the story points out, the FDA does not know if Bayer's Nexavar will prolong patients' lives. European regulators have taken a tougher stance, requiring that there be actual medical benefit from a new drug before giving manufacturers the right to sell it.

The evidence offered in the story that Nexavar will prove beneficial was encouraging, and God knows, we need new and better cancer drugs. I just learned last night that a dear friend is dying of pancreatic cancer.

But reporter Gardiner Harris failed to ask a number of critical questions. Will the Center for Medicare and Medicaid Services (CMS) require that every patient who gets Nexavar be enrolled in a clinical trial so that we'll get confirmatory data that the drug actually benefited patients (and didn't just give them encouraging x-rays with shrunken tumors)? CMS director Mark McClellan has said that the agency will demand that patients enroll in such trials as the price for the government paying for experimental cancer drugs. Even if it has been approved by the FDA, any drug that has not yet shown that it prolongs life should still be considered experimental.

Also, did the FDA require the company to complete its own study to see if the drug actually prolongs life? A recent FDA Oncology Drugs Advisory Committee heard testimony from at least six drug manufacturers who failed to complete promised trials after their drugs had been approved on an accelerated basis. The drug industry has been notorious for failing to follow through on promises made during the accelerated approval process.

Finally, will the FDA pull the drug off the market if the data from trials -- assuming they are required -- show no life-prolonging benefits from Nexavar? Harris should have gotten the FDA on the record on that critical question. If the agency is going to start rushing drugs to market based on surrogate markers of health benefit, then the least it can do is promise to remove them if they later prove useless.

Arlo Guthrie Sings For New Orleans

I read this incredibly wonderful story from the UK Independent this morning, describing Arlo Guthrie's tour along the "City of New Orleans" train route to raise money for musicians in that devastated city. Just thought I'd share.

Cleveland Clinic Takes Unprecedented Steps in Planned Pfizer Trial

The Cleveland Clinic, reeling from revelations about conflicts of interest among its top brass, has adopted what lead researcher Dr. Steve Nissen is calling unprecedented financial controls on the upcoming $100 million trial testing Celebrex’ cardiovascular safety, which will be funded by Celebrex’ maker Pfizer.

Responding to an earlier post in GoozNews, Nissen wrote to say the Clinic will appoint an oversight committee for the trial that will be made up of academic physicians without any financial ties to companies that make Cox-2 painkillers. The trial will also follow the new Journal of the American Medical Association guidelines requiring trial physicians hire an independent data analyst (not one provided by the company). Nissen also plans to turn over the trial’s entire database to the National Institutes of Health, where the public will have access to the underlying data once the trial is completed.

“Given the problems with prior research for drugs in this class, I set the highest possible ethical standards for this trial,” he said. “I want to provide the public with an answer to these critical questions with the integrity you are seeking.”

Unfortunately, he confirmed the trial will not be designed to test whether Celebrex provides superior gastrointestinal protection compared to traditional pain pills like ibuprofen and naproxen, which are cheap and sold over the counter. Pfizer initially tried to make those claims, but was forced to drop them after it was revealed the company’s researchers did not include data in the journal article that would have shown the claim to be false.

According to Nissen, all patients will receive aspirin and omeprazole (Prilosec, the over-the-counter proton pump inhibitor that is the equivalent of prescription Nexium) to “level the playing field” for GI effects. “We chose to give everyone omeprazole because selective use would unblind the trial,” he said. “If omeprazole reduces GI events in the NSAID groups, there will be comparable GI safety. Keep in mind that these are secondary outcomes. The primary goal is CV outcomes.”

Fair enough. Once this trial is over, we’ll know if taking over-the-counter Prilosec along with over-the-counter ibuprofen is just as safe as taking prescription Celebrex (assuming the trial shows that Celebrex doesn’t raise one’s risk of heart attack). But how many people will want to do that when the co-pay on Celebrex will probably be less than the out-of-pocket expenses for two drugs bought over-the-counter?

I still say it would be nice to know if one gets any GI protection by taking Celebrex for pain (assuming it doesn’t harm heart health). Because if the answer is no, then there will no reason at all to write prescriptions for the drug.

Richard Berman and the Corporate War on Science

In this busiest, most expensive advertising season of the year, readers of this morning's New York Times saw a visually stunning full page ad that contained just six words: "Hooked on Mercury Hype? Fish Scam.com.

This ad is the latest blast from Richard Berman's Center for Consumer Freedom, a non-profit "group" supported mainly by the restaurant and food industry. (I put the word "group" in quotes for a reason, which I'll get to later.) This expensive ad follows by a week the appearance of massive billboards in Times Square touting the same website. The temperature is rising on the mercury-fish issue.

The fishing industry has numerous academics willing to champion its position on the playing fields of science, whether that be in the academic literature, federal advisory committees, or on the National Academies of Science panels that have reviewed the mercury in food issue. Just recently, a study funded by the fishing industry appeared in a prominent academic journal that touted the benefits of fish fats in limiting heart disease and, perhaps, maintaining mental acuity. The study received widespread media coverage -- without mentioning that it was funded by the fishing industry.

The science of mercury is complex. But most scientists -- no matter where they stand on the issue of regulating and labeling fish -- agree that the levels of mercury in most fish species do not represent a danger to most consumers. On the other hand, most responsible scientists also admit that vulnerable populations -- the very young, women who are pregnant or nursing -- should probably think twice about how much fish they consume.

There is no debate at all about whether mercury can cause severe mental retardation and congenital deformities in people who are exposed when in utero or very young. Remember Minamata Disease? The only question is what levels can prudently be deemed safe.

You won't find any of that rational scientific discussion on Berman's website. Instead, he launches his long-standing attacks on consumer and environmental groups (including the Center for Science in the Public Interest where I work) which have raised concerns about mercury contamination and sought warning labels on food products like canned tuna that contain higher levels than what some consider prudent for populations at risk.

Berman accuses such groups of scare tactics. He also uses his heavy-handed public relations machine to attack the mainstream scientists who have conducted research in the field, even though there are plenty of scientists, most industry-funded but some not, who have engaged in the debate on the other side.

You have to dig deep into Berman's website to find out that food producer groups fund his organization. But he doesn't reveal to what extent. Filings with the IRS don't reveal his sources of funds, but in 2003 -- the most recent filing available -- the Center for Consumer Freedom pulled in $2.8 million, with $1.8 million of that going for "media and messaging." He spends $350,000 a year on his website alone, with another $650,000 poured into conducting negative research on environmental and consumer groups promoting consumer safety. The essence of this so-called consumer group is an industry-funded public relations machine.

For his efforts, Berman makes out very well, thank you. His management company pulled in $1.1 million in 2003. Using traditional yardsticks, it would appear that most of that was paid as direct salary to Berman himself since he also reported that the Center for Consumer Freedom put $115,000 into Berman's personal retirement fund.

The fishing industry and other food producer groups have every right to engage in public debates over the issue of how much mercury should be allowed in food before it is considered unsafe for vulnerable groups. But when they engage in well-funded public relations attacks on those who engage in the still evolving science, they become part of the dark forces that are seeking to undermine science itself.

Like the old saying about fish, an industry hooked on that kind of behavior is rotting from the head down.

Republican War on Science Breakout

Congrats to Chris Mooney, whose "Republican War on Science" was optioned Friday by moviemaker Morgan Spurlock ("Supersize Me") and will be reviewed on the front page of the New York Times book review on Sunday. I was especially pleased that Times reviewer John Horgan gave greater weight to the corporate influence side of the Republican war on science equation.

Much of the debate over science politicization has focused on the religious right's influence over the Bush administration on issues like Plan B, evolution, stem cell research and sex education (a typical example was a column in today's Post, which carried a small item about the Spurlock movie-in-the-making). Hopefully, Spurlock will focus on the corporate takeover of science, which has taken place not just in global warming, but in food, environment and energy policymaking as well as in the medical arena, an area not covered in Mooney's book but where I spend most of my time. It's in these arenas -- not whether teenagers can gain access to morning after pills or the latter day Scopes trial in Pennsylvania -- where corporate debasing of science truly threatens the long-term health and safety of the American people.

Krugman on Conflicts of Interest in Medicine

Paul Krugman in today's New York Times (fee to view) uses the AtriCure story at Cleveland Clinic to launch what he promises will be a series of columns on how to end conflicts of interest in medicine. Hopefully, he'll start touting some of the reforms people have been talking about, especially setting up an independent institute to conduct FDA registration trials and definitive trials for testing drugs' safety and effectiveness.

He Says, She Says, NSAIDS

The much-in-the-news Cleveland Clinic announced yesterday it will conduct a four-year trial comparing painrelievers to determine if Pfizer's blockbuster Celebrex causes heart attacks. Vioxx and Bextra, similar drugs in the Cox-2 class, have already been pulled from the market. Pfizer will fund the $100 million study.

The study will be run by Dr. Steve Nissen, who chairs the FDA's Cardiovascular Drugs Advisory Committee. No stranger to industry-funded trials, Nissen says he turns all his fees over to charity.

The design of the trial seems straight forward enough: 20,000 people at risk of heart disease (they have diabetes, high blood pressure, etc.) will be divided into three groups: one will get Celebrex, the second will get ibuprofen and the third will get naproxen. With about 700 deaths normally expected in this at-risk group, any increase should be noticeable.

A couple of comments: the newspaper accounts of this trial suggest they plan to treat patients with Prilosec for gastrointestinal side effects. It was unclear if this was prophylactically or on an as-needed basis. Hopefully it will be the latter with good data collection so the public will finally learn if Celebrex is really better at preventing GI bleeds. The first time Pfizer paid for a study of this question, their hired researcher only reported six months of data. It later came out that full-year data showed no improvement over over-the-counter medicines.

Also, I hope Nissen adheres to the Journal of the American Medical Association's new guidelines for publication of industry-funded studies by hiring an independent biostatistician to analyze the data.

Trial and Error

The following appeared in today's Chicago Tribune.

By Merrill Goozner

The specter of researchers hiding damaging data when drug companies financed their clinical trials is once again haunting the medical publishing establishment. Last week, the editors of the New England Journal of Medicine accused Merck-funded researchers of not reporting three deaths in the trial that led to the approval of Vioxx, the pain reliever subsequently pulled from the market because it caused heart attacks in some patients.

Medical editors are once again scrambling for better ways to manage these conflicts of interest. The editors of the Journal of the American Medical Association have taken the extraordinary step of requiring every industry-funded researcher who submits a study based on a clinical trial to hire an independent statistician to analyze the data. They also demanded that the principal investigator vouch for the integrity of the data and the accuracy of the data analysis--an approach that's comparable to what corporate accountants now face in the wake of the Enron Corp. scandal.

Unfortunately, piling new disclosure rules on medical researchers will not address the core problem. When industry has exclusive control over studies of its new drugs and medical devices, the most important questions usually do not get asked.

Most trials aimed at gaining Food and Drug Administration approval for a new product compare it to a placebo. Instead of asking whether it is better than what is already out there, they ask if it is better than nothing. As often as not, it is. In some cases the clinical trial protocol designed by industry-funded researchers compares the new drug to a rival drug but at doses designed to put it in the best light. That was the case with Vioxx, whose original trial compared it to high doses of naproxen to show that it caused less stomach distress. When the data showed Vioxx patients with four (now five) times more heart attacks, the Merck-funded researchers waved off that red flag by claiming naproxen probably was cardio-protective.

Merck defended its study last week by saying all the data had been turned over to the FDA, which still approved the drug. And in that sense, the company was right. The original study never tested enough people to definitively prove the drug caused heart problems--or, conversely, to show that it was safe.

Less than a year after the original trial was published, cardiologists at the Cleveland Clinic published an analysis questioning the safety of not only Vioxx, but the entire class of so-called Cox-2 inhibitors (Celebrex and Bextra are the other two approved drugs in the class). They called for a major new trial large enough to test that hypothesis. That trial was never done. Instead, industry funded hundreds of studies testing the Cox-2s for every imaginable ache and pain, which appeared in every conceivable medical specialty journal as part of the drug companies' overall marketing campaign.

The way to get better science in front of regulators and physicians (who rely on the medical literature) is to have an independent body take control of FDA registration trials. The drug and medical device industries already pay user fees to the FDA to hasten reviews of their new product applications. The user fee law is up for renewal next year. Why not expand those fees to include paying the government to conduct the final product registration trials?

It could be done through a new institute in the National Institutes of Health, which could contract with investigators at universities, independent research institutes, or the private firms that have sprung up in recent years to conduct clinical trials. The most important thing is that the trials be designed to answer the right questions--is the new product truly safe and how does its effectiveness compare to what's already out there. Regulators are facing tougher and tougher calls on drug safety. The government next year begins paying a large share of the nation's drug tab through insurance companies, which will influence which drugs seniors buy through their co-pays. Americans will be better off if those decisions are not based on information provided by a medical literature written by researchers in industry's back pocket.

Heart Palpitations at Cleveland Clinic

Every year U.S. News and World Report ranks the Cleveland Clinic as the best heart treatment center in the U.S. This morning, a Wall Street Journal investigation into the close financial ties between the head of the clinic and a Cincinnati device start-up company called AtriCure reveals the corrupting influence that financial conflicts of interest are having on America's leading medical institutions.

According to the Journal:

A venture-capital partnership that the Clinic helped found and invested in owns about 4.1% of AtriCure's stock, valued at about $7 million. The Clinic's chief executive, heart surgeon Delos "Toby" Cosgrove, sat on AtriCure's board of directors until March. He also invested personally in the fund and was one of the general partners managing it until, according to a Clinic spokeswoman, he cut his ties to the fund at the end of October. In addition, Dr. Cosgrove will be entitled to royalties for a medical device he developed that AtriCure plans to begin selling next year.

Last week, Cosgrove fired Dr. Eric Topol, who earlier in the week testified against Merck in a product liability lawsuit involving Vioxx, from academic positions that put him on the Cleveland Clinic's ethics panel. Topol's status at the clinic will be discussed today at a board of directors meeting. According to a Cleveland Plain Dealer story last Friday, Cosgrove bested Topol for the top job at the clinic.

But when the board meets today, they might want to discuss these other explosive revelations in the story:

* More than 1,200 patients at Cleveland Clinic have received the AtriCure procedure to curb atrial fibrillation despite the fact the FDA has turned down the company three times because long term data on its efficacy for curbing strokes is "sketchy." All those uses are "off label."

* At least four patients have died shortly after the procedure. Officials at the hospital say the deaths were not related to its use.

* None of the patients were told about the conflicts of interest among top officials at their hospital.

* Cosgrove never revealed his conflicts of interest when speaking about the procedure and mentioning AtriCure by name at a meeting of the American Association of Thoracic Surgery. A clinic spokesperson said his secretary checked the wrong box on the form.

* Cosgrove didn't reveal his conflicts of interest when writing a positive review of the procedure in the Journal of Thoracic and Cardiovascular Surgery. One of his co-authors, who also was a consultant to AtriCure, did.

Slingshot Against the Latest Drug Bill

There seems to be no end to bad legislation poking its head up in Congress when it comes to giveaways to the pharmaceutical industry. The latest involves a bill by Sen. Richard Burr to "encourage" the vaccine industry to take on bioterror agents. It would exempt regulatory deliberations from all freedom of information act requests and the federal advisory committee act, i.e., it would be done in "complete government secrecy." A new blog called Slingshot has a good rundown on the issue.

Will the Donut Hole Save the Democrats?

I find myself at odds with conventional liberal wisdom in the debate over the new Medicare prescription drug plan. Democrats are banking on confusion about the plan's intricacies to generate an elderly backlash that will turn into votes in next year's mid-terms. Remember Dan Rostenkowski fleeing angry oldsters? Remember the Hilary-care and the '94 election? Is the Bush drug plan next? I don't think so.

The Republican plan is fatally flawed. It forbids the government from negotiating prices the way the Veterans Administration and any respectable insurance plan does. It has limited ability to place restrictions on buying drugs that have cheaper substitutes whether brand name or generics. There's a huge gap in coverage when drug costs go over $2,500 (the so-called donut hole).

But bottom line is that for the third of seniors without drug insurance of any type, it's a lot better than nothing. You can't spend $60 billion a year and not please someone.

The latest evidence that the plan won't wreak havoc when it goes into effect next month comes from a Kaiser Family Foundation survey conducted with Hewitt Associates that was released yesterday. One of the other major charges against the Bush drug plan is that it would encourage companies that already provide drug insurance to their retirees to drop their plans in favor of the inferior government plan.

The survey asked 300 big companies with existing drug plans (nearly half of seniors have some type of insurance, usually from their former employers) whether they planned to drop coverage. Nearly 80 percent said no and would instead take advantage of a subsidy offered by the government to keep them in the game. Another 10 percent said they planned to shift their workers to Medicare but would subsidize their retirees. Only one in ten firms said they'd require their retirees to shift to the government plan.

That mild ripple will hardly be noticed. Unlike New York Times columnist Paul Krugman, who has attacked the Bush plan in a number of columns, and pollster Celinda Lake, whom I heard raise all the traditional objections at a Campaign for America's Future event last week, I predict that next fall no one will talking about prescription drugs as a political issue. The war in Iraq and a tottering economy will turn the high cost of drugs into a minor talking point at best.

That doesn't mean it isn't terrible policy. The Bush plan is the best price support program enacted by Congress since the last farm bill. According to my latest issue of the AARP Bulletin, drug prices rose at twice the rate of inflation last year, the fourth straight year they went up more than 6 percent. But the net effect of the drug plan is to substitute government payments for out-of-pocket senior expenditures to meet these rising costs.

That may be a stupid policy. It may bankrupt Medicare. But as long as millions of seniors' expenses are less at the end of next year compared to this year, it's unlikely to win many votes for Democrats that they didn't already have.

The Smallpox Vaccine Body Count

The Centers for Disease Control has just issued two new reports indicating that at least four people died from smallpox vaccinations between 2002 and 2004. The two studies appeared in the current Journal of the American Medical Association. One looked at military and government personnel who received the smallpox vaccine and the other of first responders in local communities. Put the two studies together and it looks as if at least as many people died from preparations for the next bioterror attack as died from the Fall 2001 anthrax letters.

The report on military and government employees is especially troubling, because it suggests that something is askew in the military’s adverse events reporting system. The CDC researchers looked at post-inoculation adverse events reports among the 590,400 military and 64,600 Health and Human Service personnel who received the smallpox inoculation. They found just 214 reported events. More than half were among the smaller cohort of HHS workers! The only way that 10 percent of the inoculated subjects can generate over 50 percent of the reports is if the military told its enlistees to suck it up and quit complaining when something felt wrong after their shot.

Most of the reported adverse events were mild: headaches, dizziness and brief, local paralysis at the site of the injection. However, there were 39 serious events, ranging from meningitis to seizures. These 655,000 vaccinees suffered just one death.

On the other hand, the CDC statisticians who reviewed adverse events among the 37,901 volunteers in 55 communities who took the smallpox vaccine reported three deaths. In addition, this much smaller group reported 822 adverse events – over one in every 50 shots – with 100 of them considered “serious.”

The CDC has often been criticized for being overly enthusiastic about the public health benefits from mass vaccination campaigns. So it isn't surprising that the authors of both studies called the incidence of adverse events "rare."

Someone on Capitol Hill should take a look at these reports. There clearly seems to be a problem with underreporting in the military. Moreover, three deaths among fewer than 40,000 non-federal volunteers who got the vaccine cannot accurately be called rare. If 200 million Americans got the vaccine and died at a similar rate, it would translate into 15,000 deaths.

That’s simply unacceptable, especially when there is no evidence that anyone is preparing to use smallpox as a bioterror weapon.

Susan Sontag's Heroic Final Months

Correction: my email notification for this piece contained an error. It was the poet Dylan Thomas, not Eugene O'Neill, who wrote "rage, rage against the dying of the light."

Susan Sontag’s death from cancer earlier this year left a void in American intellectual life that will be hard to fill. Two of her books, Illness as Metaphor and AIDS as Metaphor, inspired my own inquiry into the search for cures for fatal illnesses that many Americans viewed as divine retribution for a person’s habits or lifestyle.

So I was not surprised to read in her son David Rieff’s moving tribute in Sunday's New York Times Magazine (registration required) that Sontag obeyed Dylan Thomas' injunction to "rage, rage against the dying of the light" in the final months of her life. The 71-year-old New Yorker, who suffered from a rare blood cancer, spent about $300,000 of her own money for a risky and all-but-hopeless bone marrow transplant after Medicare and her supplemental insurance company turned down her request for reimbursement. When that failed, she tried an experimental drug. Not fighting for life was never an option.

Rieff, a contributing writer to the magazine, used his mother’s final struggle as a jumping off point for discussing end-of-life care in the U.S., particularly for the half million Americans who die from cancer every year. Knowing the statistics makes an oncologist’s work grim. Many cancers are not detected until they are in their final phases, when remissions are almost unheard of and even the most advanced treatments add a few months to life at best.

Rieff suggested it is the medical system’s duty to provide such care for those who want it. He criticized the work of medical ethicists like Daniel Callahan who believe society’s scarce resources would be better spent on public health interventions that reduce the incidence of cancer, which Rieff categorized as a “model based on better health outcomes for communities rather than individuals.” He quoted a New York palliative-medicine specialist who claimed that “if we as a society spent the sort of money on medical care that we spend, say, on the military, the challenge facing physicians would be very different.”

Alas, Rieff knows little about medical economics or the laws of large numbers. The Sontag case provides a textbook illustration of the costs associated with an “everything goes” approach to end-of-life care. The U.S. already spends nearly $2 trillion on health care – four times what it spends on the military. The government portions of health care – Medicare and Medicaid – alone exceed national defense.

What if the government gave every American who died of cancer the same level of treatment that Sontag fought for and received? Multiply that $300,000 times a half million people and it would add $150 billion to the nation’s health care tab. That would drive health care spending from the current 15 percent of GDP, already the highest in the world, up to 16.4 percent in one fell swoop.

Writer Shannon Brownlee last week offered another view of this difficult subject. Writing in the Los Angeles Times, she cited a study that compared the wildly varying costs of end-of-life care in three Southern California hospitals. Not only did the the high-cost intensive-care hospitals fail to prolong life, the study suggested, it wound up that "those intensive-care hospitals may actually increase a patient's chances of dying by as much as 2% to 6%. That's because hospitals, for all their power to deliver lifesaving treatments, can also be dangerous places where every drug, every treatment, every test carries the risk of error and harm.”

Most people who study the health care system as a whole, rather than viewing it as a personal interaction between the person who is sick and the health care they receive, eventually come to understand that always paying for the most expensive treatment does not always lead to the best result. Yet the researchers who point that out usually get attacked as supporting rationing and a dual health care system that favors the rich.

Sontag's final months remind us that just because you can buy it doesn’t mean that it will work. When clinical trials show that the chances of a medical intervention succeeding are vanishingly small, it is not unreasonable for a health care provider to say that it isn't worth the money or effort. What the public needs to do is insist that such decisions are based on scientific evidence and not the profit-driven "just say no" philosophy that motivates many health insurance companies.

Sontag’s approach to her impending demise was in character. She fought for life with every means at her disposal. Her grit and determination in the face of insurmountable odds was admirable. But it didn’t save her life or even extend it. Her heroic final months have something to teach a society with limited resources and an aging population. It's a lesson that is hard to accept.

Pricey Pain Pills No Better at Reducing Tummy Distress

It looks like the billions spent on expensive new Cox-2 inhibitors like Celebrex and Vioxx was wasted -- and not just because Vioxx was the likely cause of tens of thousands of heart attacks among its users.

The British Medical Journal this morning reports a new trial showing that Cox-2 inhibitors do not reduce the gastrointestinal side effects of over-the-counter pain pills like ibuprofen. This was the whole rationale for justifying the drug industry's massive investment in this new class of medicines, since they don't reduce pain any more effectively than older pain pills.

To quote from the study's conclusions: "No consistent evidence was found of enhanced safety against gastrointestinal events with any of the new cyclo-oxygenase-2 inhibitors compared with non-selective non-steroidal anti-inflammatory drugs. The use of ulcer healing drugs reduced the increased risk of adverse gastrointestinal outcomes with all groups of non-steroidal anti-inflammatory drugs."

In other words, if you are one of the 2 to 4 percent of people who suffer acid indigestion from taking over-the-counter pain pills, take another over-the-counter medication for that condition -- like Zantac. You'll save yourself or your insurer a lot of money. And you'll get the same pain relief.